Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies

NCT07270263 | Recruiting

• 1 other identifier: GUM-HEM-DOAC-2025-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Eligible participants will be randomized to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose LMWH. The primary objective is to evaluate the incidence of venous thromboembolism during a 6-month follow-up period. Secondary objectives include assessment of bleeding complications, overall survival, and treatment adherence. The results of this study may provide evidence for safer and more convenient thromboprophylaxis strategies in patients with blood cancers.

Conditions

Lymphoma; Leukemia; Venous Thromboembolic Disease; Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma; VTE (Venous Thromboembolism); PE - Pulmonary Embolism; Hematologic Malignacies

Keywords

Apixaban; Rivaroxaban; Low-Molecular-Weight Heparin; Venous Thromboembolism; Cancer-Associated Thrombosis; Hematologic Malignancies; Direct Oral Anticoagulants

Outcome Measures

Primary Outcomes (3)

• Incidence of Venous Thromboembolism (VTE)

  Number of patients who develop symptomatic or incidental venous thromboembolism (deep vein thrombosis or pulmonary embolism) confirmed by objective imaging during the study treatment period.

  6 months from randomization

• Incidence of Major Bleeding (ISTH criteria)

  Number of patients experiencing major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).

  6 months from randomization

• Incidence of Clinically Relevant Non-Major Bleeding (CRNMB)

  Number of patients experiencing clinically relevant non-major bleeding (CRNMB) according to ISTH definition.

  6 months from randomization

Secondary Outcomes (2)

• Overall Survival

  6 months

• Treatment Discontinuation Due to Adverse Events

  6 months

Study Arms (3)

APIXABAN (reduced dose)

EXPERIMENTAL

Participants receive apixaban 2.5 mg orally twice daily for at least 6 months.

Drug: Apixaban

RIVAROXABAN (reduced dose)

EXPERIMENTAL

Participants receive rivaroxaban 10 mg orally once daily for at least 6 months.

Drug: Rivaroxaban

Low-Molecular-Weight Heparin (LMWH)

ACTIVE COMPARATOR

Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months.

Drug: low molecular weight heparin (enoxaparin sodium)

Interventions

Apixaban DRUG

Oral tablet, 2.5 mg twice daily, for at least 6 months.

Also known as: Eliquis, Poltixa

APIXABAN (reduced dose)

Rivaroxaban DRUG

Oral tablet, 10 mg once daily, for at least 6 months.

Also known as: Xarelto, Mibrex, Zarixa

RIVAROXABAN (reduced dose)

low molecular weight heparin (enoxaparin sodium) DRUG

Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.

Also known as: Clexane, Neoparin

Low-Molecular-Weight Heparin (LMWH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active hematologic malignancy at the time of initiation of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma or other hematologic cancer with a Khorana score ≥ 2 points (intermediate or high risk of venous thromboembolism, VTE)
• Use of anticoagulant agents for primary thromboprophylaxis, including direct oral anticoagulants (DOACs) at reduced doses (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or low-molecular-weight heparin (LMWH) (enoxaparin 40 mg subcutaneously once daily).

You may not qualify if:

• Major bleeding within the last month (including gastrointestinal or intracranial bleeding).
• Active major bleeding.
• Hemoglobin concentration \< 8 g/dL.
• Thrombocytopenia with platelet count \<30 × 10⁹/L.
• ECOG performance status of 3 or 4.
• Expected survival \<6 months.
• History of mechanical heart valve or severe mitral stenosis.
• Estimated glomerular filtration rate (eGFR) \< 25 mL/min.
• Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).
• Acute coronary syndrome or ischemic stroke within the last 6 months.
• Anticipated significant drug-drug interactions between DOACs and anticancer agents.
• Known antiphospholipid syndrome (APS).

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Haematology & Transplantology

Gdansk, Pomeranian Voivodeship, 80-152, Poland

RECRUITING

MeSH Terms

Conditions

Lymphoma; Leukemia; Multiple Myeloma; Venous Thromboembolism; Pulmonary Embolism; Hematologic Neoplasms

Interventions

apixaban; Rivaroxaban; Heparin, Low-Molecular-Weight; enoxaparin sodium; Enoxaparin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Thromboembolism; Embolism and Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Agata Ogłoza-Puchowska, MD

CONTACT

+48 58 584 43 40; a.ogloza@gumed.edu.pl

Ewa Lewicka, Professor

CONTACT

ewa.lewicka@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no masking will be applied.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1:1 ratio to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard low-molecular-weight heparin.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: November 22, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)